NCT06381063

Non-steroidal Anti-inflammatory in Cardiac Surgery

Effect of Non-steroidal Anti-inflammatory Drugs in Pain Management After Cardiac Surgery

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication.

Conditions

• Acute Postoperative Pain
• Non-steroidal Anti-inflammatory Drugs
• Cardiac Surgery
• Pain Intensity
• Multimodal Pain Management

Interventions

Type	Name	Description
DRUG	pain management	o Pain management in both arms Intraoperative time: intravenous ketamine 0.5 mg kg-1, intravenous dexamethasone 8 mg Postoperative time: paracetamol 1 g every 6 hours a day, nefopam 20 every 8 hours a day, patient control analgesia with morphine or oxycontin
DRUG	ketoprofen	Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration
DRUG	PLacebo	Placebo twice a day, during 48 h after surgery, intravenous administration

Timeline

• Start date: 2024-03-27
• Primary completion: 2027-03-01
• Completion: 2027-07-01
• First posted: 2024-04-24
• Last updated: 2025-07-23

Locations

1 site across 1 country: France